The U.S. Environmental Protection Agency (EPA) issued a proposed regulation on August 8, 2024, to address the unreasonable risk of human health harm from 1-bromopropane (1-BP) under its conditions of use (COU), as documented in EPA’s August 2020 risk assessment for 1-BP and the December 2022 revised risk determination for 1-BP prepared under the Toxic Substances Control Act (TSCA) 89 Fed. Reg. 65066. To address the identified unreasonable risk, EPA proposes requirements to, among other things, prevent consumer access to 1-BP, restrict industrial and commercial uses of 1-BP while providing an appropriate transition period during which industrial and commercial uses of 1-BP are prohibited, and protect workers from the unreasonable risk of 1-BP at work. The EPA will hold a webinar on the topic 28 August 2024to provide an overview of the proposed rule. Comments are welcome 23 September 2024. EPA states that pursuant to the Paperwork Reduction Act, “comments on the information collection provisions will be best considered if the Office of Management and Budget (OMB) receives a copy of your comments on or before 9 September 2024.”
According to the EPA’s 1-BP risk management webpage, 1-BP is a solvent commonly used in cleaning and degreasing processes, spray adhesives, and dry cleaning. 1-BP is also used in insulation in building materials and in the manufacture of other chemicals. According to the EPA, 1-BP is used by consumers in aerosol degreasers, spot cleaners, stain removers, and insulation, among other products.
The EPA states that it wants to protect the public from exposure to 1-BP by banning all consumer uses except for insulation (because the EPA has determined that this use does not pose an unreasonable risk to humans). The consumer use ban would take effect within six months of publication of the final rule and would be fully effective within 15 months.
EPA also proposes to ban some industrial and commercial uses of 1-BP for which EPA analysis has identified safer alternatives. The ban on industrial and commercial uses would take effect six months after the final rule is published and would be fully effective within 18 months. The industrial and commercial uses that are prohibited include:
- Dry cleaning, spot cleaning and stain removers;
- Adhesives and sealants;
- Coin and scissors cleaner;
- Car care products used as engine degreasers, brake cleaners and refrigerant flushers;
- Non-stick agents for cleaning molds and release agents;
- Functional fluids used as coolants or cutting oils; and
- Materials for arts, crafts and hobbies.
EPA notes that the proposed rule would also require worker protections for several industrial and commercial uses of 1-BP that would continue but that EPA has determined pose unreasonable human health risks that must be addressed. These include use in vapor and aerosol degreasing, electronics, and electronic and metal products. To continue these uses, non-Federal workplaces would be required to implement a Workplace Chemical Protection Program (WCPP), including an exposure limit, within 12 months. EPA also proposes to require the use of chemical-resistant gloves within six months for some uses in non-Federal workplaces, including manufacturing, processing (including recycling), and disposal, to protect workers from dermal exposure to 1-BP. Federal agencies (and federal contractors acting for or on behalf of the federal government) would be required to implement a WCPP and use chemical-resistant gloves within three years.
The EPA recognizes that “many workplaces already have stringent controls in place to reduce exposure to 1-BP.” The EPA states that in some workplaces, such as those where 1-BP is used in vapor degreasing, existing controls “may already reduce exposure sufficiently to meet the inhalation exposure concentration limit proposed in this regulation.”
comment
The proposed rule is consistent with EPA’s previously proposed and final rules on other high priority substances and therefore offers few surprises. For discussion, see our comments on trichloroethylene and methylene chloride dated November 3, 2023 and May 17, 2024, respectively. We focus our discussion on issues related to 1-BP that are common in EPA’s risk assessments of high priority substances and that raise questions about whether EPA’s risk assessments and its proposed/final risk management actions meet the scientific standards under section 26 of TSCA and comply with the statutory standards in section 6 of TSCA.
In the final risk assessment for 1-BP (Final 1-BP RE), EPA did not identify any inappropriate Non-cancer Risks to workers without gloves from acute or chronic skin exposure. However, the EPA found that Cancer Risks to workers in all high exposure scenarios, assuming no gloves are worn. We mention this because the unreasonable risks identified by EPA were based on its use of an “oil study” to determine the amount of 1-BP remaining on the skin. For more information, see our July 21, 2022 memorandum. EPA has used the “oil study” in its evaluation of new chemical substances for decades. However, this study has recently come under fire within EPA. For example, EPA submitted a request to TSCA’s Scientific Advisory Committee on Chemicals (SACC) regarding the appropriateness of using the “oil study” to inform its recent draft risk assessment on 1,1-dichloroethane. For discussion, see our July 19, 2024 memorandum. The outcome of the SACC review may impact EPA’s use of the “Oil Study” in the final 1-BP RE and its subsequent use of that document for its proposed rulemaking, as 1-BP, like 1,1-dichloroethane, is a volatile organic compound (VOC). It is questionable whether the use of a highly viscous and non-volatile substance (e.g.Cooking oil) is suitable for determining the amount of a low-viscosity VOC that remains on the skin. Measuring dermal exposure, particularly to VOCs, has been a challenge for the EPA and industry.
As with other risk management rules, we question EPA’s proposal to prohibit certain COUs when EPA determines a WCPP to be protective. Bergeson & Campbell, PC (B&C®) agrees that 1-BP can cause “irreversible health effects (particularly developmental toxicity and cancer)” if exposures are not adequately mitigated under its COUs. For more information, see our July 21, 2022 memorandum. As with previous Section 6 bans, we question EPA’s proposal to ban most industrial and commercial uses of 1-BP, as it is consistent with the “to the extent necessary” provision of Section 6(a) of the TSCA if EPA determines that compliance with a WCPP will protect against the identified risks.
Section 6(c)(2)(C) of the TSCA states, among other things: “The Administrator shall, to the extent practicable, determine whether it is technically and economically feasible to Alternatives that benefit health or the environmentcompared to the use so sought to be prohibited or restricted…” (emphasis added.) EPA continues to face the complexity of its alternatives evaluations, particularly in cases such as 1-BP, where the broad range of uses requires EPA to consider a wide range of alternatives. In that case, the adhesives EPA evaluated included cyanoacrylates (superglues), solvent adhesives, and sealant—three very different classes of adhesives. As part of its proposed regulatory action, EPA proposed to ban numerous uses of 1-BP, including its use as an adhesive in industrial and commercial settings. EPA’s alternatives evaluation identified 227 products in the adhesives category. EPA also had difficulty finding complete composition information for many of the products in the alternatives evaluation, making it difficult, if not impossible, for EPA to assess whether the alternatives “benefit health or the environment.” Additionally, EPA had difficulty finding hazard data to support its alternatives evaluations. It is not clear whether the EPA considers any of the listed adhesives to be a suitable replacement for 1-BP.
It is critical that EPA’s evaluations of alternatives are well conducted and well supported so that EPA can meet its obligation to “find alternatives that will benefit health or the environment.” This is especially true when EPA seeks to ban a substance, as the existence of alternatives is a consideration in EPA’s selection of regulatory options and EPA does not want to provoke regrettable substitutions. Without additional information, it is unclear whether EPA’s evaluation of alternatives for these products meets the requirements of TSCA Section 6(c)(2)(C).
EPA’s approach (banning many COUs) deprives workplaces of the opportunity to determine whether compliance with EPA’s WCPP is possible. This fact may lead to alternatives that pose unknown, equal, or even greater hazards and do not provide mandatory workplace protections.
